Company: Tornier S.A.S. Date of Enforcement Report: 4/8/2025 Class II PRODUCT stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty. Recall Number: Z-1534-2025 REASON: Stryker identified an elevated complaint rate related to difficulties using...Read More
Company: Tornier S.A.S. Date of Enforcement Report: 4/8/2025 Class II PRODUCT stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty. Recall Number: Z-1536-2025 REASON: Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system...Read More
Company: Medtronic Neuromodulation Date of Enforcement Report: 4/8/2025 Class II PRODUCT Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators. Recall Number: Z-1543-2025 REASON: There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming...Read More
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